Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

etoposide

ifosfamide

topotecan hydrochloride

peripheral blood stem cell transplantation

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer that has demonstrated at least partial response to any salvage regimen Partial response defined as at least 50% reduction in measurable or evaluable disease for at least 4 weeks, no disease progression, no new lesions, or bone lesions that remain static for at least 8 weeks with an improvement in pain symptoms No more than 3 organs involved with metastatic disease No prior or active CNS involvement Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 64 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal No history of severe hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No severe cardiac dysfunction Ejection fraction at least 50% by MUGA No major heart disease Controlled hypertension allowed Pulmonary: DLCO at least 50% of normal OR No symptomatic obstructive or restrictive disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No uncontrolled insulin dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No significant skin breakdown from tumor or other disease No other prior malignancy in past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No active infections HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior salvage regimens for metastatic disease No prior topotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent nitroglycerin preparations for angina No concurrent antiarrhythmics for major ventricular arrhythmias

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006032

First Posted

July 5, 2000

Last Updated

December 10, 2012

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00006032

Brief Title

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

Official Title

A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (TIME) Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

March 2000 (undefined)

Primary Completion Date

April 2001 (Actual)

Study Completion Date

April 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous peripheral stem cell transplantation in treating women who have metastatic breast cancer.

Detailed Description

OBJECTIVES: I. Evaluate the efficacy and toxicity of high dose topotecan with ifosfamide and etoposide followed by autologous peripheral blood stem cell rescue in women with metastatic breast cancer. II. Evaluate the response rates, progression free survival, engraftment, and nonrelapse related mortality in women treated with this regimen. III. Evaluate the pharmacokinetic profile of high dose topotecan with respect to the efficacy and toxicity of ifosfamide and etoposide in these women. OUTLINE: Peripheral blood stem cells (PBSC) are harvested from the patient and stored. Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to -6, and etoposide IV daily over 24 hours on days -5 to -3. Autologous PBSC are reinfused on day 0. Patients are followed at 1, 3, 6, and 12 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study over 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Drug

Intervention Name(s)

ifosfamide

Intervention Type

Drug

Intervention Name(s)

topotecan hydrochloride

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer that has demonstrated at least partial response to any salvage regimen Partial response defined as at least 50% reduction in measurable or evaluable disease for at least 4 weeks, no disease progression, no new lesions, or bone lesions that remain static for at least 8 weeks with an improvement in pain symptoms No more than 3 organs involved with metastatic disease No prior or active CNS involvement Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 64 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal No history of severe hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No severe cardiac dysfunction Ejection fraction at least 50% by MUGA No major heart disease Controlled hypertension allowed Pulmonary: DLCO at least 50% of normal OR No symptomatic obstructive or restrictive disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No uncontrolled insulin dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No significant skin breakdown from tumor or other disease No other prior malignancy in past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No active infections HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior salvage regimens for metastatic disease No prior topotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent nitroglycerin preparations for angina No concurrent antiarrhythmics for major ventricular arrhythmias

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen K. Fields, MD

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Study Chair

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612-9497

Country

United States

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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